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Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)

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ClinicalTrials.gov Identifier: NCT01119729
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : May 10, 2010
Sponsor:
Collaborator:
Federal Ministry of Education and Reserach (BMBF)
Information provided by:
University Hospital, Essen

Tracking Information
First Submitted Date May 7, 2010
First Posted Date May 10, 2010
Last Update Posted Date May 10, 2010
Study Start Date Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: May 7, 2010)
Prevalence of cardiovascular diseases
Prevalence of cardiovascular diseases including coronary artery disease, congestive heart failure, peripheral arterial disease, cerebrovascular events, and valvular diseases.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 7, 2010)
Prevalence of cardiovascular disorders
Prevalence of cardiovascular disorders determined by electrocardiography, exercise testing, echocardiography, blood samples.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)
Official Title Not Provided
Brief Summary Human immunodeficiency virus (HIV) infection has been associated with a variety of cardiovascular diseases. Even most industrialised countries exhibit a growing and aging population of HIV-infected patients in the majority treated with antiretroviral drugs, the investigators still do not know much about the impact of cardiovascular diseases in this group of patients. The present study is an ongoing trial that was conducted as a prospective and multicentre survey, being schemed to analyse the frequency and clinical course of cardiac disorders in HIV-infected patients.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population included outpatients who were at least 18 years of age, had a known HIV-infection and exhibited a stable disease status within 4 weeks before inclusion of the trial. Patients were recruited during a 20-month period in a consecutive manner from September 2004 to May 2006. Written informed consent was obtained from all participants
Condition
  • Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection.
  • Effect on Cardiovascular Risk and Life Quality by Age, Gender, Classic Cardiovascular Risk Factors,
  • HIV-specific Cardiovascular Risk Factors, Cardiovascular Medication, Antiretroviral Medication
Intervention Not Provided
Study Groups/Cohorts HIV-infected Outpatients
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2010)
803
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Age > 18 years
  • Known HIV-infection
  • Outpatients
  • Written informed consent

Exclusion Criteria:

● Acute cardiovascular disease or unstable hemodynamic status in the three weeks before inclusion

• Pregnancy

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01119729
Other Study ID Numbers FKZ 01GI0205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party PD Dr. med. Till Neumann, FESC, Competence Network of Heart Failure
Study Sponsor University Hospital, Essen
Collaborators Federal Ministry of Education and Reserach (BMBF)
Investigators Not Provided
PRS Account University Hospital, Essen
Verification Date May 2010